- Kaiya Medical (dba Care Medical - Foshan)
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
White Oak Building 66
Silver Spring, MD 20993
JAN 12, 2015
VIA UNITED PARCEL SERVICE
Kaiya Medical (dba Care Medical-Foshan)
No. 1 Huabaonon Rd. (South)
Foshan, Guangdong, 528000
During an inspection of your firm located in Guangdong, China, on July 21, 2014, through July 24, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures nebulizers. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for the review, evaluation and investigation of any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is not necessary, as required by 21 CFR 820.198. For example:
a. Our investigator noted that individual complaints regarding device malfunctions were not investigated and no reason for the absence of an investigation was documented.
b. Complaint files were missing dates, results of investigations, corrective actions taken and replies to complainant.
2. Failure to establish and maintain procedures to maintain a design history file for each type of device, as required by 21 CFR 820.30(j). For example, your firm’s design input document for the KYWH2001 model nebulizer does not include functional performance requirements of the nebulizer compressor when it functions as an integrated system accompanying accessories such as VOC, ozone, and aerosol performance. These integrated system performance requirements were addressed by the firm’s consultant as part of the verification and validation activities (as described in your K101552 submittal) but never added to the design input document.
3. Failure to establish and maintain procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, the design change section of your firm’s design control procedure, (b)(4), does not explicitly require verification and validation of changes when necessary.
4. Failure to establish and maintain procedures for changes to a specification, method, process, or procedure, as required by 21 CFR 820.70(b). For example, your firm’s documented acceptance criteria applicable to finished KYWH2004 nebulizer testing include the requirement that electrical current draw be less than or equal to (b)(4) Amperes (A). However, our investigator observed that KYWH2004 compressors were tested and released with current draws from (b)(4) A to (b)(4) A, which is above the established limit. Your firm stated that the correct limit should be (b)(4) A for 115 Volt systems and that your firm’s document contained incorrect acceptance criteria. While released devices may have had appropriate power draws, the disagreement between the formally-documented acceptance criteria and the actual routine test and release practice appear to have gone undetected for over four years.
5. Failure to establish and maintain procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example, your firm’s internal audit criteria lack the requirements for conformance with the Quality System regulation, Medical Device Reporting (MDR) regulation, Corrections and Removal regulation, and other applicable FDA regulatory requirements.
Our inspection also revealed that your firm’s devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 – Medical Device Reporting (MDR). Significant violations include, but are not limited to, the following:
6. Failure to develop, maintain and implement written MDR procedures as required by 21 CFR 803.17. For example, at the time of inspection, your firm did not have written MDR procedures.
Given the serious nature of the violations of the Act, nebulizers manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you regarding the adequacy of your firm’s response and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Also, U.S. federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Inspections Support Branch, White Oak Building 66, Rm 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #440104 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch at telephone +1 301-796-6110 or fax +1 301-847-8139.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and
Piper Medical (S.D.Piper),
4807 El Camino Ave., Ste. C
Carmichael, CA 95608